Onessip Acetaminophen Oral Suspension Bubble Gum 5 mL

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It is also indicated for the temporary relief of minor aches and pains associated with conditions such as the common cold, flu, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in specific age groups, and healthcare professionals should adhere to the following dosage guidelines.

For children under 2 years of age, it is imperative to consult a physician before administration. For children aged 2 to under 6 years, the recommended dosage is 1 sachet (5 mL). For those aged 6 to 11 years, the dosage increases to 2 sachets (10 mL).

Dosing may be repeated every 4 hours as needed while symptoms persist, with a maximum of five doses per day, unless otherwise directed by a physician. It is crucial to not exceed the recommended dosage, and healthcare professionals should refer to the product carton for additional instructions and warnings regarding use.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

• Exceeding the recommended dosage while using this product is contraindicated due to the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the presence of liver disease before recommending this product for children. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

Patients should be advised to discontinue use and contact a healthcare provider if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. Patients should be vigilant for signs of liver injury and seek medical attention if they suspect an overdose.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients should stop using the product and consult a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms develop, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor before using this product if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

In the event of an overdose, immediate medical help should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effect of warfarin, which may lead to an increased risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe and effective management of anticoagulation therapy.

No additional drug interactions or interactions with laboratory tests have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Onessip Acetaminophen Oral Suspension Bubble Gum 5 mL (acetaminophen 160 mg / 5 ml). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to under 6 years, the recommended dose is 1 sachet (5 mL), and for those aged 6 to 11 years, the dose is 2 sachets (10 mL). Dosing may be repeated every 4 hours while symptoms persist, with a maximum of five doses in a 24-hour period or as directed by a healthcare professional.

Warnings include a liver warning, as this product contains acetaminophen, which can cause severe liver damage if more than 5 doses are taken in 24 hours. Additionally, there is an allergy alert for potential severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

A sore throat warning is also present; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Parents or caregivers should ask a doctor before use if the child has liver disease and should consult a doctor or pharmacist if the child is taking the blood-thinning medication warfarin.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of ONESSIP Acetaminophen Oral Suspension during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential. It is advisable to monitor for any adverse fetal outcomes in the absence of established safety data.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this medication to nursing mothers due to the potential risk to the infant.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to minimize the risk of severe liver damage.

Additionally, patients must be cautioned against the concurrent use of this product with other medications containing acetaminophen, as this may further increase the risk of severe liver damage. Regular assessment of liver function is recommended to ensure patient safety and to detect any potential adverse effects promptly.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence patient outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers should remain vigilant for any signs of adverse reactions and be prepared to implement appropriate interventions based on the clinical presentation.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if the child's pain worsens or persists for more than five days, or if a fever worsens or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in packaging that includes cartons and sachets. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Healthcare professionals should ensure that the carton or sachet is not torn, broken, or punctured prior to use, as such conditions may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Onessip Acetaminophen Oral Suspension Bubble Gum 5 mL, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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